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Medical Device Systems Engineer Jobs (NOW HIRING)

Proven

Senior Systems Engineer

Olathe, KS · On-site

$98K - $135K/yr

The Systems Engineer leads a development team to document, analyze, mitigate risks, create, test, and help with the manufacturing of complex electromechanical and embedded medical device systems ...

Proven

Senior Systems Engineer

Olathe, KS · On-site

$110 - $160/hr

The Systems Engineer leads a development team to document, analyze, mitigate risks, create, test, and help with the manufacturing of complex electromechanical and embedded medical device systems ...

Proven

Senior Systems Engineer

Olathe, KS · On-site

$98K - $135K/yr

The Systems Engineer leads a development team to document, analyze, mitigate risks, create, test, and help with the manufacturing of complex electromechanical and embedded medical device systems ...

Rishabh RPO

Senior Systems Engineer

Olathe, KS · On-site

$101K - $138K/yr

The Systems Engineer leads a development team to document, analyze, mitigate risks, create, test, and help with the manufacturing of complex electromechanical and embedded medical device systems ...

1 point system

Systems Engineer III

Bellevue, WA · On-site

Requirement - Systems Engineer III Location- Bellevue, WA 98005-Hybrid Contract W2 We are currently ... Strong understanding of medical device regulations, quality systems, and data privacy regulations.

Mitovation

Be Seen First

Systems Engineer - Medical Device Company

Ann Arbor, MI · On-site

$110K - $140K/yr

... medical device design controls. * Help stand up engineering processes and documentation at the new company office as an early technical hire. * Support buildout of a Quality Management System (QMS ...

Vantage MedTech

Senior Systems Engineer

Olathe, KS · On-site

$98K - $135K/yr

The Systems Engineer leads a development team to document, analyze, mitigate risks, create, test, and help with the manufacturing of complex electromechanical and embedded medical device systems ...

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Medical Device Systems Engineer information

See salary details

$53.5K

$127.2K

$167K

How much do medical device systems engineer jobs pay per year?

As of Sep 6, 2026, the average yearly pay for medical device systems engineer in the United States is $127,215.00, according to ZipRecruiter salary data. Most workers in this role earn between $98,000.00 and $157,000.00 per year, depending on experience, location, and employer.

What does a medical device systems engineer do?

A Medical Device Systems Engineer is responsible for designing, developing, and integrating complex medical devices and systems. They work closely with multidisciplinary teams to ensure that devices meet regulatory standards, are safe for patients, and function as intended. Their role often includes system architecture, requirements analysis, risk management, and verification and validation testing. They also collaborate with clinicians and regulatory bodies to ensure compliance with healthcare standards. Overall, their work is crucial in bringing innovative medical technologies from concept to market.

How does a medical device systems engineer typically collaborate with cross-functional teams during product development?

Medical Device Systems Engineers play a central role in coordinating with interdisciplinary teams such as mechanical, electrical, software, and quality assurance engineers, as well as regulatory and clinical experts. They are responsible for integrating various subsystems, ensuring the final device meets both technical and regulatory requirements. This often involves leading design reviews, facilitating communication between specialties, and translating user needs into system specifications. Collaboration is key, as engineers must address feedback from multiple stakeholders and ensure seamless system integration throughout the product development lifecycle.

What are the key skills and qualifications needed to thrive as a medical device systems engineer, and why are they important?

To thrive as a Medical Device Systems Engineer, you need a strong background in biomedical engineering, systems engineering principles, and regulatory knowledge, often supported by a relevant engineering degree. Familiarity with CAD software, embedded systems, FDA/ISO standards, and risk management tools is typically required. Exceptional problem-solving skills, attention to detail, and effective communication are vital soft skills for this role. These competencies ensure the safe and efficient design of medical devices that meet regulatory requirements and patient safety standards.

What is the difference between Medical Device Systems Engineer vs Medical Device Quality Engineer?

AspectMedical Device Systems EngineerMedical Device Quality Engineer
Required CredentialsBachelor's in Engineering, Systems Engineering certificationsBachelor's in Engineering, Quality Management certifications (e.g., ISO 13485)
Work EnvironmentDesign, develop, and integrate medical device systemsEnsure product quality, compliance, and risk management
Employer & Industry UsageMedical device manufacturers, R&D teamsRegulatory agencies, manufacturing firms, compliance departments
Common Search & ComparisonFocus on system integration and designFocus on quality assurance and compliance

The Medical Device Systems Engineer primarily focuses on designing and integrating medical device systems, ensuring functionality and performance. In contrast, the Medical Device Quality Engineer concentrates on maintaining product quality, regulatory compliance, and risk management. Both roles are essential in the medical device industry but serve different aspects of product development and manufacturing.

More about Medical Device Systems Engineer jobs

What job categories do people searching Medical Device Systems Engineer jobs look for?

The top searched job categories for Medical Device Systems Engineer jobs are:

Medical Device Systems Engineer jobs near you
Infographic showing various Medical Device Systems Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $127,215 per year, or $61.2 per hour.

Medical Device Systems Engineer

Sterling Engineering Inc.

North Chicago, IL • On-site

$55 - $60/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 17 days ago

Key responsibilities

  • Lead and coordinate Use-Related Risk Analysis (URRA) activities across assigned medical device and combination product programs.

  • Facilitate cross-functional meetings and collaborate with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams to identify hazards, use errors, risks, and mitigations.

  • Support key systems engineering activities, including system architecture, user needs, product requirements, traceability, risk management, and change management.

Job description

Job Title: Medical Device Systems Engineer
Location: North Chicago, IL
Hire Type: Long-Term Contract (1+ year)
Target Pay Rate: $55.00 – $60.00/hour
Work Schedule: Onsite Monday-Friday
Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), & ESOP

Job Summary:
Seeking a Systems Engineer to support the development of innovative medical devices and therapeutic combination products within a highly regulated R&D environment. This role will primarily focus on Use-Related Risk Analysis (URRA) while also supporting broader systems engineering activities, including Design Inputs, Risk Management, Traceability, Systems Integration, and Design History File (DHF) architecture. The Systems Engineer will coordinate cross-functional risk assessments for drug delivery systems such as on-body devices, pre-filled syringes, autoinjectors, mixing devices, and electromechanical pumps, partnering closely with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams throughout clinical and commercial development.

Must Have Skills:
  • 3–5 years of experience in pharmaceutical, medical device, combination product, or another regulated industry.
  • Hands-on experience with Use-Related Risk Analysis (URRA), Human Factors, or Risk Management.
  • Strong experience with Design Controls and Design History File (DHF) documentation in a regulated environment.
  • Experience working in a cross-functional, matrixed organization with strong communication and facilitation skills.

Job Duties:
  • Lead and coordinate Use-Related Risk Analysis (URRA) activities across assigned medical device and combination product programs.
  • Facilitate cross-functional meetings and collaborate with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams to identify hazards, use errors, risks, and mitigations.
  • Support key systems engineering activities, including system architecture, user needs, product requirements, traceability, risk management, and change management.
  • Develop and maintain Design Control documentation and Design History Files (DHF) in accordance with applicable regulations and internal procedures.
  • Support risk assessments, including URRA, Design FMEA, and Process FMEA activities.
  • Monitor project schedules, milestones, risks, and deliverables; escalate issues and delays as needed.
  • Support integration of third-party development activities, including vendor communications and deliverable reviews.
  • Drive consistent execution of systems engineering and risk management processes and identify opportunities for improvement.

Qualifications:
  • BS in Engineering, Science, or a related technical discipline with 5+ years of relevant experience, or MS with 3+ years of experience.
  • 3–5 years of experience in pharmaceutical, medical device, combination product, or another regulated industry.
  • Experience with Use-Related Risk Analysis, Human Factors, Risk Management, and/or product development.
  • Strong experience with Design Controls and Design History File (DHF) management.
  • Working knowledge of systems engineering principles, including requirements definition, traceability, risk management, product architecture, and change management.
  • Experience with applicable regulatory standards such as FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, or EU MDR.
  • Strong organizational, facilitation, communication, and analytical skills.
  • Ability to influence cross-functional teams, manage competing priorities, and work effectively in a highly matrixed environment.
  • Experience with project tracking/document management tools and third-party vendor coordination preferred.
  • Experience supporting drug delivery systems, medical devices, or combination products preferred.


Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.